Shiwatrix Lifesciences delivers globally accredited toxicology and regulatory consulting that helps medical device and pharmaceutical innovations reach patients safely, faster, and in full compliance with international standards.
Bringing a medical device or pharmaceutical product to market takes more than great engineering — it takes proof, backed by rigorous science, that the product is safe. Shiwatrix Lifesciences builds that scientific foundation, from Biological Evaluation Plans and Chemical Characterization to Toxicological Risk Assessments, led by globally accredited ERT and DABT-certified toxicologists.
Our assessments are led by ERT and DABT-certified toxicologists, recognized credentials in international toxicology and regulatory science.
Decades of hands-on regulatory and scientific work across medical devices and pharmaceuticals inform every report we deliver.
From the first biological evaluation plan to final regulatory documentation, we support the entire safety and compliance journey — not just one piece of it.
250+ projects delivered for 80+ clients across the globe speak to the reliability of our process.
No two products are alike, and neither are our assessments. Every evaluation is built around the specific product, intended use, and regulatory pathway.
We work fluently across ISO 10993, ISO 14971, FDA guidance, and European MDR, so your submission speaks the right regulatory language wherever you take your product to market.
Biological Evaluation Plans, Toxicological Risk Assessments, Chemical Characterization, Biological Evaluation Reports, Gap Analysis, and ISO 18562 breathing gas pathway evaluation.
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Hazard identification, exposure assessment, toxicological risk assessment, regulatory submissions, evaluation of impurities, and pharmacovigilance support.
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Decades of Expertise
Projects Delivered
Global Clients
Accredited Experts
We start by understanding your product, its intended use, and your target regulatory pathway.
Our accredited toxicologists and scientists carry out the biological, chemical, or toxicological evaluation your product requires.
We compile clear, audit-ready scientific reports and regulatory documentation aligned to the standards your market requires.
We remain available for regulator queries, follow-up questions, and updates as standards evolve.
If a regulator or reviewer challenges our reports or findings, our team responds directly and reworks the assessment, staying engaged until your product is fully ready for approval.
Our team's expertise is certified and recognized by leading international toxicology and regulatory bodies.
Talk to our regulatory and scientific experts today.
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